This invention pertains to post-surgical devices for colostomy patients to facilitate regular irrigation of the bowel through a stoma opening.
Patients who have had the lower portion of the bowel, including the rectum, removed surgically, require a new opening for elimination of waste matter. The new artificial opening, or stoma, made on the abdominal wall into the large bowel and termed a colostomy, has no voluntary sphincter control by the patient. In order to avoid involuntary bowel movement through the stoma, it is customary and desirable for the patient periodically to take an enema, commonly called irrigation, through the stoma. The frequency required of this irrigation is generally daily, or perhaps every second day, in order to keep the bowel free from involuntary discharges.
In general, the irrigation system employed consists of a water reservoir and means for suspending it at about shoulder level to supply gravity flow of the water through a tube leading from the reservoir to the stoma. A sheet plastic sleeve is adapted to be attached to the patient by a plate member and supporting belt, and the sleeve has provision at or near its upper end for encompassing the stoma of the patient and making a fluid tight engagement with the abdominal wall to protect the patient from spilling or soiling. The lower end of the sleeve is open for discharge of the irrigation fluid and waste into a toilet or other receptacle. Provision is made at the upper end of the sleeve for ducting the irrigating fluid through the sleeve and into the stoma. In general there are two types of sleeves available to the patient, one or the other of which is selected in accordance with whether the patient employs the so-called open method or closed method of irrigation.
Sleeves adapted for use in the open method are supplied to the patient with the axially upper end left open, as well as the lower end, and are provided with a lateral opening in the sleeve wall a short distance below its open upper end. The open upper end permits the patient to insert his hand into the top of the sleeve for manipulation of the catheter or cone during insertion into the stoma, preparatory to irrigation. Some form of closure means, such as a clip or other device, is employed to close the upper end of the sleeve when the cone or catheter tube is withdrawn after the irrigating fluid has entered the bowel through the stoma. The sleeve, with its lateral opening in registration with the stoma, is held in place on the patient by an annular body frame or plate secured by a belt about the patient's waist. One such open method system is shown in U.S. Pat. No. 3,910,274, FIG. 3.
In the closed system, the lower end of the sleeve is open as before, but the axially upper end is closed by being secured about the opening of the body frame that encompasses the stoma area. Alternatively, the axially upper open end of the sleeve may be closed by a weld seam, in which case a lateral opening must be provided in it for attachment to the body frame.
The introduction of the irrigation fluid into the stoma is made by means either of a soft flexible catheter tube, or by means of a smooth cone. In the closed method, the catheter may be passed through a suitably small hole in the outer wall of the sleeve, in registry with the plate opening surrounding the stoma. Some form of seal or flap is provided at the catheter hole to prevent the irrigating fluid from escaping through the hole in the sleeve on return of the fluid at the completion of the irrigation. Such arrangements are shown, for example, in U.S. Pat. Nos. 2,154,202, 2,504,872, 2,902,036, 2,928,393 and 3,292,625.
Where, however, it is desired to use a cone rather than a catheter tube, a much longer opening is required in the outer wall of the sleeve, and the closure or sealing methods employed for catheters is not satisfactory or practical for cones, principally because of the difficulty in providing a large opening with tight closure to prevent leakage. Suggestion has been made to incorporate a cone integrally with a sleeve in order to permit use of the closed system of irrigation and also to avoid leakage around the cone where it passes through the sleeve. See U.S. Pat. No. 3,830,235. However, use of the cone has heretofore generally necessitated use of the open method of irrigation, with its attendant disadvantages. These include possible spilling, splashing and soiling by inadvertent escape of the irrigating fluid or waste discharge at the open upper end of the sleeve before it has been closed off after removal of the cone. Closing of the sleeve requires some form of clip or equivalent device, and the attachment of these on the sleeve can present a practical problem of manual dexterity for a patient.
Many of the irrigation sets now available are designed only for use in the open method with a plastic sleeve which is meant to be rinsed clean after each irrigation, dried and re-used repeatedly. Apart from the problems of maintaining this equipment sanitary, reusable sleeves are inherently more expensive than single-use, disposable plastic ones.
Until several years ago, only the catheter method of irrigation through the stoma was available, and thousands of patients still use this method. More recently the cone method has been supplanting the catheter because of its many advantages, more especially avoidance of bowel injury and more efficient irrigation performance. Some patients with obese abdominal walls, or with redundant tissue at the stoma, have difficulty in inserting the cone to a sufficient depth. In these cases, use of the cone supplemented by a catheter extension to provide an inch or so of catheter projecting from the cone is an advantage.
Irrigation by the closed method generally is more comfortable for a patient and gives greater peace of mind. As mentioned above, this system is easily adaptable to a catheter or rectal tube by providing a small opening in the outer sleevewall in registry with the stoma opening, but no satisfactory arrangement has heretofore been provided for use of a cone under the conditions imposed by the closed upper end of the sleeve. It may often be desirable, moreover, for the patient to select between use of the catheter, cone, or combination of the two, and the prior irrigation systems have not afforded such flexibility.